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The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status

Terminated

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Galantamine

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring Alzheimer Disease, Dementia, Sleep Disorders, Galantamine, Reminyl

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Alzheimer-type dementia according to the definition of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV-TR) and a diagnosis of possible or probable Alzheimer-type dementia, according to NINCDS-ADRDA classification (American Psychiatric Association, 2000
McKhann, G. et al, 1984)
should have moderate dementia, evidenced by a Mini-Mental Status examination (MMSE) score between 12 and 20, including these limits
At inclusion, a recent CT or MRI must be available
Physical examination and the electrocardiogram (ECG) performed at the screening visit must be normal or consistent with the underlying illness in the study population
History of sleep behavior changes (eg: insomnia, daytime sleepiness, changes in sleep/wakefulness cycle) 2 or more weeks before, reported by the caregiver
Patients should have a caregiver sufficiently informed of their condition and, if possible, living with them
Patients (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

History of other neurodegenerative disorders, such as Parkinson's disease, Pick disease or Huntington's chorea, Down syndrome, Creutzfeldt-Jakob disease (patients with mild extrapyramidal signs for which no treatment is required are not excluded from the trial)
Clinically significant cardiovascular disease expected to limit the ability of the patient to participate and complete the study
Any history of epilepsy or seizures (except for febrile seizures in childhood)
Clinically significant psychiatric condition, according to the DSM-IV criteria, particularly major depression or schizophrenia currently
Active peptic ulcer (treatment of the disease started < 3 months or treatment is not successful
Clinically significant liver, renal, pulmonary, metabolic, or endocrine disorders
Clinically significant urinary flow obstruction
History of or suspected alcoholism or drug abuse in accordance to the DSM-IV criteria, in the past year, or previous history of prolonged abuse
Previous therapy with memantine or an acetylcholinesterase inhibitor (including galantamine)
Patients receiving antipsychotics, hypnotic or sedative agents (those patients who need this kind of medication during the study would be withdrawn from the study and replaced)
Bedridden patients

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Galantamine

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks

Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.

Secondary Outcome Measures

Full Information

NCT ID

NCT01181921

First Posted

August 12, 2010

Last Updated

April 15, 2014

Sponsor

Janssen-Cilag, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01181921

Brief Title

The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease

Official Title

Phase IV Study for the Assessment of Modulating Effect of Galantamine (Reminyl PRC) on Circadian Rhythm in Patients With Moderate Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

The recruitment rate was very low (one screening failure and one early withdrawal patient)

Study Start Date

May 2011 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen-Cilag, S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the modulating effect of galantamine on circadian rhythm in patients with moderate Alzheimer's disease.

Detailed Description

This is a pilot, single-group, interventional, prospective study including patients with moderate Alzheimer's disease, treated with galantamine. Galantamine is thought to benefit the cognitive functioning of those with Alzheimer's disease. The starting treatment dose is 8 mg/day for 4 weeks. The initial maintenance dose of galantamine is 16 mg/day. Patients should be maintained on 16 mg/day for 4 weeks. An increase to the maintenance dose of 24 mg/day should be considered on an individual basis after the appropriate assessment including evaluation of clinical benefit and tolerability. For individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered. The primary objective is the assessment of the modulating effect of galantamine (Reminyl PRC) on circadian rhythm (wake/sleep) in patients with moderate Alzheimer's disease. The secondary objective is to assess the perception of the physicians, caregivers and patients themselves on sleep-wake disorders in patients with moderate Alzheimer's disease before and after treatment with galantamine. Sleep disturbances will be assessed by two actigraphy measures: one, before starting treatment, and the other, 12 weeks after the first actigraphic measure. The primary endpoint is the day/night ratio measured by the actigraphy before and after treatment with galantamine in patients with moderate Alzheimer-type dementia. Concerning the Efficacy Measures, the Actigraphy will be used as a method to assess the modulating effect of galantamine on circadian rate. The impact of this modulating effect on the caregivers, patients themselves and physicians will be assessed by three questionnaires: the Zarit Caregiver Burden Interview (ZBI), the Pittsburgh Sleep Quality Index (PSQI) and the Clinical Global Impression (CGI), respectively. Patient safety will be monitored. It is estimated that the study period will range from September 2010 to the second quarter of 2011.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Alzheimer Disease, Dementia, Sleep Disorders, Galantamine, Reminyl

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Galantamine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Galantamine

Intervention Description

Type= range, unit= mg, number= 8-24, form= capsule, route= oral use. The starting dose will be 8 mg/day for 4 weeks. Subsequently, the initial maintenance dose will be 16 mg/day for 4 weeks. Then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.

Primary Outcome Measure Information:

Title

Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks

Description

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Alzheimer-type dementia according to the definition of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV-TR) and a diagnosis of possible or probable Alzheimer-type dementia, according to NINCDS-ADRDA classification (American Psychiatric Association, 2000 McKhann, G. et al, 1984) should have moderate dementia, evidenced by a Mini-Mental Status examination (MMSE) score between 12 and 20, including these limits At inclusion, a recent CT or MRI must be available Physical examination and the electrocardiogram (ECG) performed at the screening visit must be normal or consistent with the underlying illness in the study population History of sleep behavior changes (eg: insomnia, daytime sleepiness, changes in sleep/wakefulness cycle) 2 or more weeks before, reported by the caregiver Patients should have a caregiver sufficiently informed of their condition and, if possible, living with them Patients (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: History of other neurodegenerative disorders, such as Parkinson's disease, Pick disease or Huntington's chorea, Down syndrome, Creutzfeldt-Jakob disease (patients with mild extrapyramidal signs for which no treatment is required are not excluded from the trial) Clinically significant cardiovascular disease expected to limit the ability of the patient to participate and complete the study Any history of epilepsy or seizures (except for febrile seizures in childhood) Clinically significant psychiatric condition, according to the DSM-IV criteria, particularly major depression or schizophrenia currently Active peptic ulcer (treatment of the disease started < 3 months or treatment is not successful Clinically significant liver, renal, pulmonary, metabolic, or endocrine disorders Clinically significant urinary flow obstruction History of or suspected alcoholism or drug abuse in accordance to the DSM-IV criteria, in the past year, or previous history of prolonged abuse Previous therapy with memantine or an acetylcholinesterase inhibitor (including galantamine) Patients receiving antipsychotics, hypnotic or sedative agents (those patients who need this kind of medication during the study would be withdrawn from the study and replaced) Bedridden patients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

Organizational Affiliation

Janssen-Cilag, S.A.

Official's Role

Study Director

Facility Information:

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

The CIRCADIAN Study: Evaluation of Modulating Effect of Galantamine on Circadian Rhythm in Patients With Mild to Moderate Alzheimer's Disease

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